Posts Tagged ‘misoprostol’

Maternal Health Commodities: Case Studies from Bangladesh, India, Ethiopia, Nigeria, Tanzania, and Uganda

Tuesday, May 22nd, 2012 by KateMitch

Last month, the Maternal Health Task Force was invited by the Secretariat to the UN Commission for Life Saving Commodities for Women and Children to complete a landscaping of maternal health commodities in 6 countries. The MHTF, in collaboration with Global Health Visions, prepared a working document, titled UN Commission on Life Saving Commodities for Women and Children: Country Case Studies, that takes a closer look at the status of 3 maternal health commodities in 6 countries where maternal mortality remains a persistent problem: Bangladesh, India, Ethiopia, Nigeria, Tanzania, and Uganda.

 

The document provides critical insights into the various barriers to access to oxytocin, misoprostol, and magnesium sulfate. Post-partum hemorrhage (PPH) and Pre-Eclampsia/Eclampsia (PE/E) are two of the leading causes of maternal death. PPH can be treated, and often prevented, with uterotonic medicines—such as oxytocin and misoprostol. Similarly, magnesium sulfate is an effective treatment for managing PE/E.

 

Oxytocin, misoprostol, and magnesium sulfate are all now included on the WHO Model Lists of Essential Medicines—but significant gaps exist between international policies and actual access to medicine in communities, and health facilities around the world.

 

The document also highlights innovations and best practices for increasing access to essential commodities—exploring the use of mobile technologies to share information about stock outs, solar powered refrigerators, single-dose and disposable injectable medicines, task-shifting, and pooled procurement strategies as tools for expanding the availability of essential maternal health medicines for women in developing countries.

 

The report concludes that: “While findings differ across countries, one aspect is clear – significantly more research is needed to fully capture the state of maternal health commodities in these countries, and probably others. Building on this initial review, a well-planned series of consultations with in-country stakeholders is a critical next step. A comprehensive understanding of the status and accessibility of these commodities is a necessary component of ensuring access to high quality maternal health services for millions of women around the world.”

 

Access the full report here.

 

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10 Reasons to Celebrate the Health of Moms—and Those Working to Improve Maternal Health—this Mother’s Day!

Friday, May 11th, 2012 by KateMitch

Mother’s Day 2012 provides a good occasion to celebrate accomplishments in the field over the past year. The Maternal Health Task Force shares ten exciting developments.

 

 

  1. The State of the World’s Midwives report provided the first comprehensive analysis of midwifery services in countries where the needs are greatest.
  2. The MHTF & PLoS launched an open-access collection on quality of maternal health care.
  3. UNICEF & UNFPA launched the UN Commission on Life-Saving Commodities, to increase access to maternal, child, and newborn health commodities.
  4. Joyce Banda, an advocate for women’s health & rights, became Malawi’s first female president.
  5. The White Ribbon Alliance, along with many partners, developed the Respectful Maternity Care Charter: The Universal Rights of Childbearing Women.
  6. Direct Relief International, Fistula Foundation, & UNFPA partnered to develop the first-ever Global Fistula Map, outlining the global landscape of the issue.
  7. The first-ever estimates of preterm birth rates by country were published in a new report, Born Too Soon: A Global Action Report on Preterm Birth.
  8. Save the Children’s 13th State of the World’s Mothers report focused on nutrition during the period from pregnancy through the child’s 2nd birthday, the first 1,000 days
  9. The World Health Organization added Misoprostol to the List of Essential Medicines, a critical step toward preventing post-partum hemorrhage.
  10. Melinda Gates announced plans to help raise $4 billion to dramatically increase access to family planning around the world by 2020.

 

Please add to the list in the comments!

 

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A Closer Look at Lifesaving Maternal Health Medicines

Friday, March 23rd, 2012 by KateMitch

Written by Rachel Wilson,  the senior director of policy and advocacy at PATH and co-chair of the Maternal Health Supplies Working Group

 

Today could be the beginning of a significant, life-saving shift for maternal health. The United Nations Children’s Fund  and the United Nations Population Fund launched a high-level commission to improve access to essential but overlooked health supplies, including medicines that could save the lives of millions of women.

 

Worldwide, an estimated 350,000 women die during pregnancy and childbirth every year. Most maternal deaths can be prevented with affordable and effective medicines, such as oxytocin, misoprostol, and magnesium sulfate. Together with skilled health workers and strong health systems, these medicines can transform women’s health in developing countries.

 

 

“The day of birth is the most dangerous day in the life of a woman and her child,” stated commission co-chair Prime Minister Jens Stoltenberg of Norway in today’s announcement. “The fact that women do not get the care they need during childbirth is the most brutal expression of discrimination against women. To prevent these tragic and unnecessary deaths is not only a humanitarian urgency of highest priority, but a key investment for social and economic development.”

 

We know what the main barriers and gaps are, including weak logistics and supply chains, inadequate regulatory capacity to protect people from sub-standard or counterfeit medicines, lack of affordable medicines, and confusion about how, why, and when to use them. And we know from other health areas that it is possible to overcome these challenges in even the poorest and most isolated communities. Solving these systemic and structural problems now will help countries strengthen and provide critical obstetric health services well into the future.

 

“There is no doubt that lives can be saved by increasing access to affordable and effective medicines and health supplies. We must all make a difference and the time is now,” said commission co-chair President Goodluck Jonathan of Nigeria.

 

With technical and political leadership, the commission can contribute significantly to improving women’s health worldwide by:

  • Quantifying the unmet need for maternal health medicines so manufacturers can adequately scale up to meet that need and cost estimates to achieve universal coverage can be calculated.
  • Identifying global and national level expenditures for maternal health medicines so any gaps between necessary and actual funding levels can be determined and filled.
  • Exploring bulk purchasing mechanisms so that prices remain low while at the same time creating more attractive markets for manufacturers.
  • Decreasing the prevalence of substandard medicines.
  • Improving national regulatory capacity to ensure that only quality medicines are available and that new medicines can effectively enter the market.
  • Promoting the national registration of essential maternal health medicines as identified by the World Health Organization.
  • Supporting new product development and delivery innovations.
  • Strengthening management information systems to ensure medicine availability and avoid stockouts but not too far in advance to risk expiration.
  • Monitoring policy implementation so gaps may be addressed.
  • Improving knowledge and skills of health care providers and supply chain managers.
  • Building the evidence base and human resource capacity for administration of maternal health medicines by lower-level workers so that women may receive appropriate care when delivering in their community.

 

With a concentrated and continued focus on high-impact health supplies, the commission’s work could make unprecedented leaps toward the Every Woman Every Child movement’s goal to save 16 million lives by 2015.

 

To learn more about the UN Commission on Life-Saving Commodities for Women and Children, visit http://www.everywomaneverychild.org/resources/un-commission-on-life-saving-commodities.

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This International Women’s Day, Give Women the Power to Help Themselves with Three Little Pills

Thursday, March 8th, 2012 by Christopher Lindahl

Written by: Koki Agarwal, Director, MCHIP

 

The following originally appeared on the MCHIP blog. It is posted here with permission.

 

Bleeding to death after delivery is the leading cause of maternal death worldwide, with the greatest burden of disease in the developing world. Women who give birth at home are especially vulnerable to succumb to this largely preventable cause of death. To address this, the MCHIP Project, which is USAID’s flagship maternal and child health program, is training community health workers to educate women in their homes—and arming them with just three tablets of misoprostol, a potentially lifesaving drug.

 

Easy to administer, misoprostol is an oral uterotonic in tablet form that does not require refrigeration or storage in a cool, dark place, or administration by a skilled attendant. Because women can die within two hours of the onset of bleeding with postpartum hemorrhage (PPH), a key prevention strategy must include advance provision of misoprostol to expectant mothers for self-administration after birth.

 

MCHIP projects in a number of countries have demonstrated that antenatal care providers and health workers in the community can effectively distribute—and women can safely use—misoprostol for PPH prevention during home birth. In Tanzania, for example, women who delivered at home and did not use misoprostol were almost nine times more likely to need additional interventions for the treatment for PPH than those who used the drug . Moreover, distribution of the drug directly to women has proved to increase the proportion of women who are covered by use of a uterotonic drug immediately after birth. Providing them with the three tablets of misoprostol has also not prevented communities from seeking delivery care at a facility. In fact, in almost all MCHIP programs, as a consequence of effective counseling, more women have delivered with a skilled attendant.

 

This International Women’s Day, let’s continue our work to help women help themselves. Rarely the decision-makers in their households, women in low-resource settings—where the majority of these deaths occur—are often assumed to be incapable of correctly taking misoprostol . An expectant mother is the only person who will surely be there at the time of her delivery. Who better, then, to receive misoprostol and be trained to take it responsibly?

 

In the public health community, we know well the close link between a mother’s health and that of her children—if a mother passes away in childbirth, there is a more than 75% chance that her baby will not survive. Therefore, whatever we can do to ensure that when women deliver at home, they have access to misoprostol and related training, the less we have to worry about finding someone to help her should a life-threatening hemorrhage occur. And the more confident we can feel in her continued health, the more confidence we can have in the security of her family and the health of her larger community.

 

Ideally, all women would have access to a skilled attendant for their birth, and the necessary emergency obstetric care to handle life-threatening emergencies. As we work toward that goal, putting misoprostol in the hands of all women who may need it is the best way forward.

 

Happy International Women’s Day!

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Translating promise into reality: Misoprostol for post-partum hemorrhage

Monday, December 19th, 2011 by Christopher Lindahl

Written by: Ann Starrs, President, Family Care International

 

The following originally appeared on the Family Care International blog. It is reposted here with permission.

 

Every five minutes, somewhere in the developing world, a woman who has just given birth bleeds to death. Almost all of these cases of postpartum hemorrhage (PPH) can be prevented or effectively treated if every woman has access to essential health services and medicines, and particularly to uterotonic drugs.

 

Misoprostol is one such drug. Research has shown it to be safe and effective for stopping postpartum bleeding, the leading cause of death in childbirth. Misoprostol offers several unique advantages, particularly for use in low-level health facilities and in community and home birth settings: it Misoprostol tabletsdoesn’t require refrigeration, is simple to administer, is inexpensive, and is widely available. But many women still do not have access to this critical medicine – even though misoprostol is on the World Health Organization’s Model List of Essential Medicines for the prevention of PPH, is on the national essential drug lists in many countries, and is included in many global and national clinical practice guidelines.

 

In “Misoprostol for postpartum hemorrhage: Moving from evidence to practice,” a commentary we co-authored for the January 2012 issue of the International Journal of Gynecology & Obstetrics (IJGO), Beverly Winikoff (president of Gynuity Health Projects) and I note the “growing consensus that misoprostol is a safe and effective option for preventing and treating PPH, particularly in settings where oxytocin — the gold standard drug — is not available or where its administration is not feasible.” This article grew out of a multi-year collaboration between Gynuity and FCI to evaluate misoprostol and to promote wider understanding, use, and acceptance of misoprostol for preventing and treating PPH. In it, we outline the unique challenges to expanding women’s access to and use of misoprostol, including:

  • Misoprostol’s use for a range of indications, which has resulted in controversy about its possible “misuse.” Misoprostol can be used to induce abortion early in pregnancy, and can cause complications if used incorrectly before or after delivery, which has made some governments, donors, and health care professional reluctant to promote it even for appropriate uses.
  • Evidence-based guidelines and clinical protocols that, in many countries, do not reflect the latest research, and a lack of provider training in its proper use.
  • Misconceptions and misperceptions held by policy makers and health practitioners, including a fear — unsupported by the evidence — that promoting misoprostol’s use in home births could deter women from giving birth at health facilities.

There is no panacea for reducing maternal mortality: as we point out in the article’s conclusion, “no drug can replace the need for strengthened basic and emergency obstetric care services; for more and better-trained health workers; for clean, well-equipped facilities; and for culturally-sensitive, high-quality maternal health care.” But misoprostol is an essential tool, one that can help us to deliver on the world’s promise to improve maternal health. To make progress in ensuring that every woman has access to a uterotonic to prevent or treat PPH, the medical and health policy communities must work together to translate research findings on misoprostol into changes in policy, knowledge, and clinical practice.

 

Read the full article here.

 

Learn more about FCI’s work on misoprostol and PPH here.

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USAID Technical Series: Prevention and Management of PPH and PE/E

Wednesday, August 3rd, 2011 by Christopher Lindahl

Yesterday afternoon, a group of maternal health practitioners met at the Ronald Reagan Building in Washington, DC. Dr. Jeffrey M. Smith of MCHIP gave a presentation on a report he co-authored called “Prevention and Management of Postpartum Hemorrhage and Pre-Eclampsia/Eclampsia” (PDF) as part of the USAID Maternal Health Technical Series.

 

The paper reports on various themes and topics such as the active management of the third stage of labor, education and training, misoprostol, and magnesium sulfate. Dr. Smith and his colleagues collected survey responses from groups in 31 countries on their maternal health policies, implementation and management.

 

They developed some binary metrics (Yes/No) to determine how far along a given country is in their maternal health efforts to provide a global snapshot. Then, the answers were represented in graphs to allow readers to see where gaps may exist. For example, their research found that all 31 countries surveyed had national policies in place for the use of magnesium sulfate use for preeclampsia/eclampsia, however, in only 48% of countries was magnesium sulfate regularly available in facilities. Dr. Smith argues that this indicates that we do not necessarily need to worry about national policy but drug availability.

 

Finally, the conversation turned towards the need for better data and more detail on maternal health. Most of our metrics, number of antenatal care visits or percentage of births attended by a skilled professional, are based simply on contact with the health system, but do not reveal anything about the content or quality of those visits. Dr. Smith also lamented the fact that we only have regional data for causes of maternal death, while for child mortality, country level data is available.

 

The report then lays about concept maps to show the progress being made (or lack thereof) in the 31 surveyed countries. Each indicates where programming is completed, exists, or does not exist on topics relating to PPH and PE/E.

 

The report concludes:

Findings from this survey indicate a disparity between nationally approved policies and education guidelines to reduce PPH and PE/E and actual services delivered. Multiple, creative approaches are needed—and are being implemented—to address this gap between policy and practice. Possible approaches include quality improvement initiatives, change management strategies and mHealth approaches…More emphasis must be placed on training and supervision to increase utilization of high impact interventions, specifically use of AMTSL and MgSO4. This analysis also demonstrated the need to consider and address indirect utilization barriers for these high-impact interventions.

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Misoprostol for postpartum hemorrhage: from evidence to action

Monday, August 1st, 2011 by Christopher Lindahl

Written by: Shafia Rashid, Senior Program Officer, FCI Global Advocacy program.

 

The following was originally posted on FCI’s blog. It is reposted here with permission.

 

Around the corner from the New York Stock Exchange, where financial decisions of global importance are made every day, more than 50 obstetricians, midwives, women’s rights advocates, public health programmers, researchers, and policy makers from around the world gathered last week for discussions on a different, but equally momentous, subject. FCI, working in collaboration with Gynuity Health Projects, brought together this diverse group for a two-day meeting to help shape policy and advocacy on the use of the drug misoprostol for the prevention and treatment of postpartum hemorrhage (PPH). In the developing world, uncontrolled post-partum bleeding is the leading cause of death in childbirth, killing a woman every five minutes.

 

In studies conducted by Gynuity and others, misoprostol has been shown to be a safe and effective medicine both for the prevention and for the treatment of PPH. While another drug, oxytocin, is generally recognized as the “gold standard” among uterotonic drugs for preventing or treating PPH, misoprostol has significant advantages for use in settings where maternal mortality is high and most births take place outside of hospitals: misoprostol is delivered in tablet form, and — unlike oxytocin — requires neither refrigeration nor intravenous administration. Earlier this year, misoprostol was added to the World Health Organization’s Model List of Essential Medicines for the prevention of PPH, providing another opportunity to expand women’s access to this safe and inexpensive medicine. Misoprostol, originally developed for treatment of stomach ulcers, is also used for a range of reproductive health indications, including induction and augmentation of labor and medical abortion.

 

The New York meeting aimed to translate the scientific evidence on misoprostol’s safety and efficacy into effective strategies for expanding women’s access to misoprostol at the country level. After reviewing the scientific research, the global clinical and policy guidelines that shape the use and availability of misoprostol, and the strategies being used by misoprostol advocates and programmers, participants discussed opportunities, barriers, and challenges related to promoting greater access to misoprostol for PPH. Human rights experts framed how access to misoprostol is a human right enshrined in several international frameworks, including the Universal Declaration of Human Rights. Presentations and discussions highlighted the need not only to drive policy change at the country level (e.g., getting misoprostol registered for this indication, including it on national essential drug lists, and incorporating it within national clinical norms and guidelines), but also to ensure that these policies are adequately implemented and funded so that they translate into real progress for women.

 

Presenters from Nepal, Kenya, and Ecuador shared lessons from successful efforts to achieve policy approval and expand distribution of misoprostol, and participants from countries including India, Tanzania, Uganda, Burkina Faso, and Laos also contributed their experiences. These discussions included promising results from several countries where distribution of misoprostol tablets to women in their communities has proven effective in addressing the risk of hemorrhage among women who give birth at home — where more than half of births in the developing world still take place — with extremely low levels of diversion of the drug for other uses, incorrect dosage or timing of administration, or other signs of poor compliance. Attendees also learned about advocacy campaigns in related sectors, including emergency contraception, medical abortion, and the HPV vaccine for cervical cancer, and considered how those lessons may be applied to improving access to misoprostol for PPH.

 

Looking ahead, FCI will work with our partners to develop and implement an advocacy and communications strategy that will drive real progress in helping countries, health care providers, and women themselves address the leading cause of maternal death. Please stay tuned to The FCI Blog for more information as this exciting and important project moves forward.

 

To read FCI’s mapping report on advocacy for access to misoprostol, click here: Mapping_Miso_For_PPH.

 

To read about FCI’s work on misoprostol for PPH, click here.

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WHO approves misoprostol to prevent hemorrhage

Monday, May 23rd, 2011 by Christopher Lindahl

Written by: Shafia Rashid, Senior Program Officer, Global Advocacy, FCI

 

The following was originally published on the FCI blog. It is reposted here with permission

 

Last week, the WHO Expert Committee on the Selection and Use of Essential Medicines approved the inclusion of misoprostol for the prevention of postpartum hemorrhage (PPH) on the WHO List of Essential Medicines. PPH,or severe bleeding following childbirth, is one of the major causes of maternal death and disability in developing countries. The Expert Committee noted that “600 micrograms [misoprostol] given orally is effective and safe for the prevention of PPH” in settings where oxytocin, currently the standard of care to prevent PPH, is not available or feasible. Moreover, the committee moved misoprostol from the complementary to the core list of essential medicines, validating the drug’s important role in women’s health.

 

Structure of the misoprostol molecule/www.3dchem.com

Structure of the misoprostol molecule

Misoprostol, a prostaglandin, offers several potential advantages over oxytocin for managing PPH in resource-constrained settings. It is widely available in developing countries, is relatively inexpensive, can be transported and stored without refrigeration, and can be administered without an injection.

 

The addition of misoprostol to the WHO List of Essential Medicines is an important step forward in making the drug more widely available for PPH, and provides a critical opportunity for disseminating clear, evidence-based information to ministries of health, regulatory authorities, health system managers, health workers, and other audiences.

 

Strong, effective, and consistent advocacy at the global, regional, and country levels is critical for improving women’s access to misoprostol for both prevention and treatment of PPH. FCI is working with Gynuity Health Projects and other partners to develop an evidence-based advocacy agenda and communications plan to harmonize and disseminate messages on the use of misoprostol for preventing and managing PPH.

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Decision on Addition of Misoprostol to WHO EML for Treatment & Prevention of Postpartum Hemorrhage

Monday, May 23rd, 2011 by Christopher Lindahl

May 19, 2011

 

Dear Colleagues:

 

It has been several months since you lent your support to add misoprostol for prevention and treatment of post-partum hemorrhage (PPH) to the World Health Organization’s (WHO) Model List of Essential Medicines. The 18th Expert Committee on the Selection and Use of Essential Medicines met in Accra, Ghana in March 2011 to review the applications for misoprostol to be added to the WHO’s essential medicines list (EML) for the prevention and treatment of PPH. There was a huge outpouring of support for the inclusion of misoprostol for both indications by international policy-making and programmatic agencies and outside expert reviewers that positively reviewed both applications.

 

On May 6th, the Expert Committee published its results which “add misoprostol to the [Essential Medicines] List, for the prevention of PPH in settings where parenteral uterotonics are not available or feasible.” Additionally the committee moved the drug from the complementary to the core list of essential medicines. The committee’s report cited a recently completed study from Pakistan, demonstrating that “there may be a benefit from use of misoprostol by traditional birth attendants or assistants trained on the use of the product at home deliveries. Unfortunately, the committee did not approve the inclusion of misoprostol for its specific PPH treatment indication at this time. The unedited draft report is available on the WHO website at: http://www.who.int/medicines/publications/unedited_trs/en/index.html.

 

Regarding misoprostol for PPH treatment, the committee expressed some concerns which led to their decision to withhold approval at this time. The major stumbling blocks noted by the committee appear to be concerns about the very limited (e.g. no) data to support the use of misoprostol for treatment of PPH among women who have previously received prophylactic misoprostol to prevent PPH as well as about possible side effects after 800 micrograms (mcg) of sublingual misoprostol. . The committee also indicated a worry that any recommendation to use misoprostol for both PPH prevention and treatment could reduce attempts to make oxytocin more available. It is important to underscore however, that the committee also noted in its report that WHO guidelines and other internationalguidelines recommend misoprostol for both the prevention and treatment of PPH due to atony, where parenteral uterotonics are not available.

 

We are pleased that the EML will now include the 200-mcg tablet of misoprostol for its PPH prevention indication, in addition to:

  1. a 25‐mcg vaginal tablet, for use in induction of labor;
  2. a 200‐mcg tablet to be used in combination with mifepristone, for termination of pregnancy (where legally permitted and culturally acceptable);
  3. a 200‐mcg tablet for the management of incomplete abortion and miscarriage.

Moreover, the addition of misoprostol to the Core List is a strong validation of the drug’s role in women’s health. Future research will address misoprostol use for PPH treatment after its use for PPH prevention. Such use of the drug is certainly already a reality in places where oxytocin is not yet available and/or feasible to use. These results and other supportive data will be submitted to the Expert Committee on the Selection and Use of Essential Medicines again for consideration in two years.

 

Many organizations, including Gynuity Health Projects and Venture Strategies Innovations, continue to support the addition of misoprostol to the Model List of Essential Medicines for its specific post-partum hemorrhage treatment indication and will continue to advocate for its inclusion in the future.

 

We thank you again for your support of this issue.

 

Sincerely,

 

Jennifer Blum, M.P.H., Gynuity Health Projects
Ndola Prata, M.D., M.Sc., Venture Strategies Innovations, Associate Professor in Residence, University of California, Berkeley
Kirsten Moore, Reproductive Health Technologies Project

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Misoprostol added to WHO list of essential medicines for PPH

Thursday, May 19th, 2011 by Christopher Lindahl

Postpartum hemorrhage (PPH) is the leading cause of maternal mortality, accounting for about 25% of all maternal deaths. Misprostol is an easy to use drug that is shown to be successful in preventing PPH. Earlier this month, the World Health Organization added misoprostol to its List of Essential Medicines for the prevention of PPH. The news is the culmination of years of research and advocacy.

 

Jill Sheffield of Women Deliver writes:

Now that misoprostol is recognized as an essential medicine, we must take the next step and help translate this development into increased awareness, approval, and access in every country with a high rate of maternal death. The small white pill is inexpensive, stable even in warmer climates, and is easy-to-use, making it ideal for community-level delivery where oxytocin is not available or cannot be safely used. Simply put, this pill can save lives by preventing women from bleeding to death during and after delivery.

 

Krishna Jafa of PSI also lauds the decision:

The WHO’s designation of misoprostol in its List of Essential Medicines is significant because many national governments follow WHO guidelines when drawing up their own national essential medicines list; drugs on national essential medicines lists are often prioritized by governments for budgetary allocations and procurement. We can now expect that misoprostol will be more widely available in the places it is most needed.

 

Finally, Melanie Holden of Venture Strategies Innovations says:

Within VSI we are elated. This is a tremendous boon for women’s health and solidifies misoprostol’s role in making childbirth safer. As co-authors of the application with Gynuity Health Projects, we are enormously proud of this accomplishment and how it will translate to lives saved around the globe.

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